1. Field of the Invention
The present invention generally relates to medical equipment. More specifically, the present invention relates to headgear used in the treatment of sleep apnea.
2. Related Art
Sleep apnea is a breathing disorder characterized by brief interruptions of breathing during sleep. Certain mechanical and structural problems in the airway of a person cause the interruptions in breathing during sleep. In some people, apnea occurs when the throat muscles and tongue relax during sleep and partially block the opening of the airway. When the muscles of the soft palate at the base of the tongue and the uvula (the small fleshy tissue hanging from the center of the back of the throat) relax and sag, the airway becomes blocked, making breathing labored and noisy and even stopping it all together. Sleep apnea also can occur in obese people when an excess amount of tissue in the airway causes it to be narrowed. With a narrowed airway, the person continues his or her efforts to breathe, but air cannot easily flow into or out of the nose or mouth. Unknown to the person, this results in heavy snoring, periods of no breathing, and frequent arousals (causing abrupt changes from deep sleep to light sleep). Source: Facts About Sleep Apnea, National Institute of Health, Publication No. 95-3798, September 1995.
During the apneic event, the person is unable to breathe in oxygen and to exhale carbon dioxide, resulting in low levels of oxygen and increased levels of carbon dioxide in the blood. The reduction in oxygen and increase in carbon dioxide alert the brain to resume breathing and cause an arousal. With each arousal, a signal is sent from the brain to the upper airway muscles to open the airway; breathing is resumed, often with a loud snort or gasp. Frequent arousals, although necessary for breathing to restart, prevent the patient from getting enough restorative, deep sleep. Id.
Nasal continuous positive airway pressure (CPAP) is the most common effective treatment of sleep apnea. In this procedure, the patient wears a respiratory mask over the nose during sleep, and pressure from an air blower forces air through the nasal passages. The air pressure is adjusted so that it is just enough to prevent the throat from collapsing during sleep. The pressure is constant and continuous. Nasal CPAP prevents airway closure while in use, but apnea episodes return when CPAP is stopped or used improperly. Id.
Variations of the CPAP device attempt to minimize side effects that sometimes occur, such as nasal irritation and drying, facial skin irritation, abdominal bloating, mask leaks, sore eyes, and headaches. Id.
One device for the treatment of sleep apnea is shown in U.S. Pat. No. 5,361,416 (Petrie et al.). The Petrie et al. device comprises a head cover and chin strap for treating sleep apnea. However, the Petrie et al. device is not a CPAP device.
Another device, this one for the reduction of snoring activity, is shown in U.S. Pat. No. 5,687,743 (Goodwin). The Goodwin device comprises a head strap assembly for reducing snoring activity. However, the Goodwin device is also not a CPAP device.
Another device, this one for a Nasal Mask and a headgear, is shown in U.S. Pat. No. 5,724,965 (Respironics Inc.). The Respironics Inc. device comprise a respiratory mask and the headgear to hold this respiratory mask in place. This Respironics Inc. device is a CPAP device.
The present invention is a CPAP headgear for assisting in the treatment of sleep apnea. The present invention may use a standard CPAP respiratory mask supplied with air under pressure by an air blower or other source. The present invention generally comprises an improved Headgear, preferably having a Lip Strap, and a Clip or Extenders and the ability to attach to and hold the CPAP respiratory mask in place.
The Headgear is specifically designed with two side portions, which are preferably separate panels with various sections for proper connection to each other and to the wearer. Each side portion encircles an ear with an open area where the ear will fit and thereby stay a distance from the ear with material that goes upwards toward the top of the head. One side separates into two straps near the top that connect across the top of the head to the second side. Another strap extends from the back of the left side piece that encircles the ear and around the nape of the neck to the right side that encircles the right ear and back over toward the left, connecting upon itself. With these various attachments of the two side panels to each other, the two pieces of the head cover are connected over the top of the head and also connected together across the back of the neck. This feature of not putting pressure on or touching the ears of the wearer adds a great level of comfort to the CPAP apparatus.
The present invention preferably also has a Lip Strap. The Lip Strap extends from and is attached to a first front lower side of the Headgear, wraps around the user""s head at a location under and over the user""s lower lip, and extends and attaches to a second lower front side of the Headgear. The Lip Strap needs to be snug, but not tight against this location, thereby keeping the lower lip against the teeth and thereby disallowing air to escape from the user""s mouth. The teeth may be in a relaxed and open position and the Lip Strap will still disallow the air to escape from the user""s mouth. The use of such a Lip Strap is preferred, but optional.
The main problems with prior CPAP headgears which are overcome in the present invention include: the prior art CPAP headgears are uncomfortable to wear, especially when the headgear slip or rides up on the wearer""s head, hurting the wearer""s ears; and the prior art CPAP headgears do nothing to force the user to breathe through the user""s nose, thereby resulting in a dry mouth when the user awakens the next morning. This head cover, made of two pieces, one for each side of the head, encircle the ears with a hole in the middle that is placed over the ears and is large enough as not to touch the ears. The side pieces extend upward to the top of the head and connect to each other across the top of the head. The side pieces also extend around and connect at the nape of the neck thereby keeping the Headgear in place.
The preferred material is also an important component that keeps the Headgear in place. Another benefit of the present invention over prior CPAP headgears, is the non-elastic and still flexible characteristic of the preferred material of manufacture, in comparison to the stretchy plastic and/or elastic used in many of the prior art articles. Being non-elastic and still flexible allows the present invention to firmly hold the user""s head without becoming too tight, which is a major problem of the prior art articles. The preferred two headgear panels have substantially continuous inner surfaces except for the apertures that receive the ears, that is, broad and gentle surfaces for increased comfort compared to the lack of comfort typical of narrow straps or ties. The preferred material of manufacture also allows for the hook side of a hook and loop type fastener to attach anywhere on the outside of this Headgear which allows a multitude of adjustment possibilities.
Another problem with prior CPAP headgears which is overcome in the present invention includes: the prior art CPAP headgears are difficult to take off and put back on without loosening the straps that attach to the respiratory mask and thereby losing the adjustment, especially when one has to un-attach the straps holding the respiratory mask each time one removes the respiratory mask. The Clip is a bent hook made of plastic or metal that connects to the side elastic strap on one side of the headgear and attaches to the respiratory mask and allows the removal without loosening the straps that hold the respiratory mask in place. The open extender is on one side and either part of the respiratory mask or is a bent wire that is attached to the respiratory mask and can be used for this same purpose as the Clip.
Another problem with prior CPAP headgears which is overcome in the present invention includes: the prior art CPAP headgears attach to the respiratory mask in the area near the nose or the center part of the respiratory mask. When attaching in this area, the respiratory mask needs a lot of pressure against the face to keep the air from leaking from the respiratory mask that is next to the face. This also, usually requires a piece that attaches to the respiratory mask and goes above the nose, between and above the eyes and usually then has a part that rests against the face near or above and between the eyebrows.
Extenders can either be made of strong plastic and be made as part of the respiratory mask or they can be made separately and attach to an existing respiratory mask. Extenders that are part a respiratory mask are plastic hooks that are positioned below the mask and with one side having a closed hook and the other side an open hook through which the side straps of a headgear are fastened. Extenders that are additional to an existing respiratory mask are made of a strong and lightweight metal that on the upper end have a bent open circle which will fasten, when closed, to the existing mask attachment where the strap usually attaches and the lower end to be bent in a closed hook on one Extender and with an open hook on the other Extender, to which the side straps of the Headgear will fasten. This will drop the area to which the Headgear straps attach to the respiratory mask below the nose and mask. In addition to the open Extender making it easy to take the Headgear off and on, the lowering of the attachment the Extenders give to the ability to keep the respiratory mask in place without needing as much pressure against the face, and they keep the respiratory mask away from the eyebrow and forehead area. They do this by dropping the attachment below the nose and mask which then positions the part of the respiratory mask that is above the nose slightly away from the face in the eyebrow area and still allows the respiratory mask air to seal and not allow air to escape where it is against the face. By lowering the attachment area, as the extenders do, seems to not require that the mask have as much pressure against the face and still keep the air from leaking from the respiratory mask that is next to the face.